FDA.reportPublic FDA data

CERAGEM Master V9

Primary DI
08809643652087
Brand
CERAGEM Master V9
Company
CERAGEM Co., Ltd.
Model
CGM MB-2401
Published
2025-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IROVibrator, Therapeutic
IRPMassager, Powered Inflatable Tube
ISAMassager, Therapeutic, Electric
JFBTable, Physical Therapy, Multi Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IROVibrator, TherapeuticPhysical Medicine1
IRPMassager, Powered Inflatable TubePhysical Medicine2
ISAMassager, Therapeutic, ElectricPhysical Medicine1
JFBTable, Physical Therapy, Multi FunctionPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809643652087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809643652087088096436520878809643652087

GMDN Terms#

Term, Definition table
TermDefinition
Massage table/couch, line-poweredA mains electricity (AC-powered) table designed for various kinds of complementary therapy (e.g., massage, acupuncture, aromatherapy, reflexology, kinesiology). It will typically consist of a framework with a flat table top surface which may have a head section that can be manually adjusted into a raised position. The height of the table is electrically adjusted. It may incorporate a face hole (the patient's face fits into this when lying prone), a headrest, and an armrest(s). This device is typically known as a massage/therapy table, couch or bed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688326136
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809494000747CERAGEM Master S4CGM MS-23012025-03-07
08809494001164CERAGEM Master S4CGM MS-23022025-03-07
08809494000686CERAGEM Master V7CGM MB-23012025-02-12
08809494000983CERAGEM Master V7CGM MB-23022025-02-12
08809643652476CERAGEM Master V5CGM MB-19022025-02-12
08809494000082CERAGEM Master V6CGM MB-17012021-03-31
08809494000099CERAGEM Master V6CGM MB-17022021-03-31
08809494000075CERAGEM Master V4CGM MB-19012021-03-12
08809494000006CERAGEM Master V3CGM MB-11012016-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809040526721AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyMaxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526790Air Relax Classic Model AR-1.0 Leg Recovery System-Size 3Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809494000686CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809494000983CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
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08800066190026PlasonSeoulinMedicare Co.,Ltd.ISA2022-05-27
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08809802643376LF900DAESUNG MAREF CO.,LTD.IRP2022-05-09